A Relative Bioavailability Study of 180 mg Fexofenadine Hydrochloride Tablets Under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax = Maximum Observed Concentration.
研究概览
简要总结
This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd. with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All volunteers selected for this study will be healthy, non-smoking men and women 18 to 55 years of age, inclusive, at the time of dosing. The volunteer's body mass index (BMI) is less that or equal to
- •If female and :
- •of child bearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
- •is postmenopausal for at least 1 year; or
- •is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
排除标准
- •Volunteers with a recent history of drug or alcohol addiction or abuse.
- •Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
- •Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- •Volunteers demonstration a positive hepatitis B surface antigen screen, hepatitis C antibody screen or a reactive HIV antibody screen.
- •Volunteers demonstrating a positive drug abuse screen when screened for this study.
- •Female volunteers who are currently breast feeding.
- •Female volunteers who are demonstrating a positive pregnancy screen.
- •Volunteers with a history of allergic response(s) to fexofenadine or related drugs.
- •Volunteers with a history of clinically significant allergies including drug allergies.
- •Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- •Volunteers who currently use or reports using tobacco or nicotine-containing products within 90 days prior to Period I dosing.
- •Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
- •Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will by advised not to donate blood for four weeks after completing the study.
- •Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- •Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
- •Volunteers who report taking any prescription medication in the 14 days prior to Period I dosing, with the exception of topical products without systemic absorption.
- •Volunteers who have been on an abnormal diet during the 28 days prior to Period I dosing.
- •Volunteers who report an intolerance of direct venipuncture.
研究组 & 干预措施
1
干预措施: Fexofenadine 180 mg tablets (Drug)
2
干预措施: ALLEGRA® 180 mg tablets (Drug)
结局指标
主要结局
Cmax = Maximum Observed Concentration.
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on Cmax.
AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on AUC0-inf.
次要结局
未报告次要终点